Intraosseous needle

ABSTRACT

An intraosseous needle having a threaded shaft with a passageway extending substantially therethrough, a solid and pointed tip at one end thereof, the tip having a plurality of cutting edges which facilitate boring through a bone. The shaft also includes two side ports in communication with the passageway to allow fluids to pass through the needle into the interior of the bone after successful insertion thereof. There is a hub at the opposite end of the shaft, whereby the needle is adapted to couple with an appropriate gripping device. A handle is provided in the shape of a ball knob and is adapted to telescopically and grippingly receive the hub of the needle. The hub and handle are both equipped with mutually engaging torque-transmitting surfaces.

REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.884,323, filed May 11, 1992, which is a continuation of U.S. patentapplication Ser. No. 627,020, filed Dec. 13, 1990, now abandoned, whichis a continuation-in-part of U.S. patent application Ser. No. 261,699,filed on Oct. 24, 1988, now abandoned, by the same inventive entity, andentitled Intraosseous Needle Assembly.

FIELD OF THE INVENTION

The present invention relates to infusion needles, and moreparticularly, to an intraosseous infusion needle having a tip adapted tobore directly into the patient's bone.

BACKGROUND OF THE INVENTION

In a variety of medical emergencies, the patient's life may hinge uponthe ability of the physician or medical attendant to administer aparticular fluid into the patient's bloodstream. In emergency situationssuch as on the battlefield, at traffic accident scenes or in theemergency room, the patient is often in shock, has low blood pressure,is bleeding profusely and may be thrashing about. Under suchcircumstances, finding and gaining access to a suitable blood vessel canbe all but impossible, the resulting delay in administering drugs to thepatient possibly being fatal. In the case of children or infants in anyemergency, even the largest veins are so small that they may not belocated. Even if located, an infant's largest available vein may be sosmall that stable infusion access may not be possible.

One alternative to venous access, recently reintroduced, is theintraosseous route. The medullary cavity of the long bones is composedof a rich spongy network of venous sinusoids which drain into a centralvenous canal. Blood then exits the venous canal by nutrient or emissaryveins into the circulation. Fluids or drugs injected into the medullaryarea usually diffuse only a few centimeters, enter the bloodstream andreach the heart--all in only about 10 seconds from injection into themedullary cavity. It is important that any devices which provideintraosseous access have a lumen of a size adequate to allow for theinfusion of relatively large volumes of fluid over a short period oftime. Current intraosseous infusion procedures (meaning before theimprovement described herein) utilize a hollow needle having a beveledtip and a trocar or stylet. With the styler telescopically positionedwithin and extending partially out the bevelled end of the needle, theneedle and trocar assembly is forceably and perpendicularly advancedagainst and through the desired bone until the cortex has been puncturedand the needle and trocar tip has advanced into the medullary space. Thefrocar is then withdrawn, leaving the open end of the needle directly inthe rich vascular network. Various complications, however, have madeintraosseous infusion a less than ideal option. Although the needle andtrocar assembly have a sharp, pointed tip, the medullary cavity may notbe able to be penetrated under normal pressure. Too much force in tryingto puncture the bone sometimes results in a bent needle, a brokenneedle, splintering of the bone, sliding off the bone and puncturingadjacent tissue or, more commonly, the needle is accidentally forcedthrough the opposite side of the bone. Even if the needle is properlyinserted into the medullary cavity, movements by the patient can easilydislodge the needle or cause it to be moved so that the end opening isoccluded. These complications commonly arise in cases involvingintraosseous infusion of infants and children. Additionally, fluid mayleak from the puncture site into surrounding tissues. For persons olderthan six, the bones are too hard to successfully perform intraosseousinfusion utilizing current procedures without realizing an extremelyhigh incidence of the above complications. The current procedure has,therefore, typically been limited to children less than six years oldand only after several attempts have been made to achieve venousinfusion.

What is needed is an intraosseous infusion device which decreases theincidence and severity of the above described complications, which iseasier to insert, which is more stable once inserted, prevents leakageof infused fluids, and, most importantly, which can be used in subjectsof all ages.

SUMMARY OF THE INVENTION

Generally speaking, there is provided an intraosseous needle whichallows for precise control and placement of the needle duringintraosseous infusion procedures.

An intraosseous needle has a threaded shaft with a passageway extendingsubstantially therethrough. At the leading end of the shaft is a solidpointed tip having a plurality of cutting edges, one of which coincidesat a point with a thread to allow the threads to catch once the boringis completed. In the preferred embodiment, the tip is shaped like athree sided pyramid and is adapted for rapid and precise boring into thebone of adults, children or infants. The shaft further defines a pair ofside ports, one located in the valley between the leading or first fullthread and the second thread and the other side port located between thesecond thread and the third thread. The side ports are located 270°apart and are both in communication with the passageway of the shaft. Ahandle in the shape of a ball knob is adapted for telescopic andgripping connection to the trailing end of the needle and both thehandle and the trailing end of the needle are equipped with mutuallyengaging, torque-transmitting faces.

It is an object of the present invention to provide an improvedintraosseous needle which reduces the incidence and severity of thecomplications attendant in current procedures and devices.

It is another object of the present invention to provide an intraosseousneedle which is easy to use.

It is still another object of the present invention to provide anintraosseous needle which is more stable once inserted.

It is still another object of the present invention to provide anintraosseous needle which is suitable for use in subjects of all ages.

Further objects and advantages of the present invention will becomeobvious from the following description of the preferred embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of an intraosseous needle in accordance with oneembodiment of the present invention.

FIG. 2 is a fragmented plan view of the needle of FIG. 1 which has beenrotated 90° about its axis.

FIG. 3 is a plan view, partly in section, of a handle and intraosseousneedle of the present invention.

FIG. 4 is a front view of the handle of FIG. 3.

FIG. 5 is a front end view of the intraosseous needle of FIG. 1.

FIG. 6 is a fragmented plan view of an intraosseous needle in accordancewith the preferred embodiment of the present invention.

FIG. 7 is a front end view of the intraosseous needle of FIG. 6 showingthe angular relationships between side ports and cutting edges.

FIG. 8 is a plan view of the intraosseous needle of FIG. 6 rotated aboutits axis to show the cutting edge which coincides at a point with theridgeline defined by the threads.

FIG. 9 is a diagrammatic side view of the proximal tibia showing thepreferred access site of the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is thereby intended, such alterations and furthermodifications in the illustrated device, and such further applicationsof the principles of the invention as illustrated therein beingcontemplated as would normally occur to one skilled in the art to whichthe invention relates.

Referring now to FIGS. 1 and 2 there is shown an intraosseous needle 10in accordance with one embodiment of the present invention. Needle 10includes a hub 11, a threaded shaft 12 and boring means. In thisembodiment, the boring means is a fluted pencil point tip 13. Behind theboring means, there are 0.150-16 buttress threads 15 on shaft 12 havinga major diameter of 0.150" and a minor diameter of 0.110", both to atolerance of 0.005". Recall that the threads are shaped to ensure thatthe needle is stable and prevents leakage once inserted. The lead angleor helix angle θ is defined as the angle formed by a plane (indicated at17) drawn tangent to the pitch helix and a plane (indicated at 18)normal to the axis 21 of threaded shaft 12. The leading and trailingthread surfaces are indicated at 18' and 19, respectively. The trailingthread angle α is defined here as that angle formed by a plane(indicated as 20) drawn tangent to trailing thread surface 19 and plane18 normal to axis 21. Trailing thread angle α in the preferredembodiment is equal to the helix angle θ. That is, plane 17 is parallelto plane 20. As shown in the embodiment of FIG. 1, trailing thread anglealpha is approximately 8°, while leading surface 18' forms an angle withnormal plane 18 of about 30°, that is, leading and trailing surfaces 18'and 19 are not parallel.

Hub 11, located at the rearward or trailing end of threaded shaft 12,forms the female end for connection to a conventional Luer-type fittingand includes a generally cylindrical portion 22 and an annular flangeportion 23. A generally cylindrical section 24 is located betweencylindrical portion 22 and threaded shaft 12. The diameters of flangeportion 23 and cylindrical section 24 are approximately equal and bothare greater than the diameter of cylindrical portion 22. Cylindricalsection 24 has a pair of diametrically opposed and mutually parallelflat faces 25. Flange portion 23 likewise has a pair of diametricallyopposed and mutually parallel flat faces 26 which are coplanar withcorresponding flat faces 25. A large diameter bore 29 with a standardLuer taper is defined in hub 11 and extends from end 30 throughcylindrical portion 22 and partially through cylindrical section 24.Bore 29 receives the male portion of the Luer-type fitting. A smallerdiameter axial passageway 31 is in communication with bore 29 andextends from bore 29 forwardly through nearly the entire length ofthreaded shaft 12. A pair of side ports 33 and 34 extend radiallyoutwardly from axial passageway 31 near tip 13. Side ports 33 and 34 arelocated 90° apart. Side port 33 opens outwardly in the valley betweenthe leading or first full thread 36 and the second thread 37. Side port34 opens outwardly in the valley between the second thread 37 and thethird thread 38.

Fluted pencil point tip 13 is substantially conical with the conicalouter surface 40 forming an angle Φ with axis 21 of approximately 20°. Apair of diametrically opposed flutes 41 and 42 are milled into the endof tip 13 using a ball end mill. The end mill used to cut flutes 41 and42 is aligned to rotate about an axis which is parallel with axis 21during the milling process. The foremost end 43 of leading thread 36 isinterrupted by the milling process such that leading thread 36terminates into one of the flutes 42. The milling process thus formssharp boring edges 44 and 45 between flute 41 and conical surface 40 andsharp boring edges 46 and 47 between flute 42 and conical surface 40.The border between leading thread 36 and flute 42 likewise forms a sharpcutting edge at 43. As shown in FIG. 1, flute 42 is machined furtherrearwardly than flute 41. In the present embodiment, the complete axiallength of flute 41 measured from tip 48 is 0.14 inches while thecomplete axial length of flute 42 measured from tip 48 is 0.16 inches.

A complete intraosseous needle assembly includes, along withintraosseous needle 10, a corresponding gripping means or grippingelement which is handle 50 (FIGS. 3 and 4). Handle 50 comprises aplastic ball knob 51 having an axial bore 52. An insert 53 for grippingneedle 10 is sized to be tightly received within bore 52. Insert 53 isfixed within bore 52 by appropriate means such as by gluing. Insert 53is adapted to couple with needle 10 and has a central opening 55 whichis generally cylindrical with opposing planar faces 56. Opening 55 issized to receive the complimentary shape of hub 11 with its cylindricalsection 24 and opposing flat faces 25. Insert 53 further includes stub57 which extends forwardly into opening 55. As hub 11 of needle 10 isreceived within opening 55, stub 57 enters bore 29 of hub 11. Stub 57 isstepped slightly forwardly such that its largest diameter, at its base58, is the same as or just slightly larger than the inner diameter ofbore 29. As stub 57 advances into hole 29, the larger diameter at base58 of stub 57 wedges within bore 29 forming a snug fit between needle 10and handle 50. Hub 11, bore 29, opening 55 and stub 57 are sized tocreate a mutually snug connection sufficient to cause hub 11 to remainfirmly lodged within handle 50 but to be removed under a moderatemanually applied tensile force.

Referring now to FIGS. 6, 7 and 8, there is shown an intraosseous needle70 in accordance with a preferred embodiment of the present invention.Needle 70 includes a hub, not shown but identical to hub 11 describedearlier, a threaded shaft 72 and a boring end 73. Like the embodimentdescribed earlier, shaft 72 includes an axial passageway 74 incommunication with side ports 75 and 76. Also, the thread size isidentical to the embodiment described earlier, which ensures thestability of the needle once implanted and the patency of the side ports(described infra). Like the embodiment described above, the thread angleΩ is approximately 45°. The thread angle Ω is the angle measured betweena line 76' parallel to axis 81 and a line 76" which extends through theaxis 81 and is coextensive with the face 90 of the thread. The boringend 73 is formed in the shape of a regular three-sided pyramid whereinthe three cutting edges 77, 78 and 79 culminate in pointed tip 80.Cutting edges 77, 78 and 79 are 120° apart about axis 81, which isdefined by the needle. Boring end 73 can be formed by grinding or anyother suitable means which leaves cutting edges 77, 78 and 79 relativelysharp. The grind angle c, which in this case is approximately 24°,defines the slope of each side of the pyramid. The boring end 73 isprecision ground so that cutting edge 79 coincides with helical threadridgeline 82 at point 83. This arrangement couples boring end 73 tothreaded shaft 72, allowing the threads to engage the bone when theboring is completed.

Also of significance is the location of side ports 75 and 76 withrespect to both the threads of shaft 72 and the cutting edges of boringend 73. Side ports 75 and 76 must be sized and situated to avoid therisk that they might become clogged with tissue during insertion ofneedle 70 into bone in order to ensure that potentially life-savingfluids can be passed thru the needle to the desired location within thebone. With this in mind, side port 76 is axially aligned with cuttingedge 78 and is located in the valley between the first two successivethreads 84 and 85 which are uninterrupted by the surfaces and edgesforming boring end 73. Side port 75 is likewise situated between twoadjacent threads but is angularly displaced about axis 81 from side port76. This angle β is approximately 270°.

The intraosseous needle assembly is used as follows:

An intraosseous needle 10 or 70 is firmly secured to a handle 50. Thepreferred site is marked and an incision is made in the skin down to thebone. The preferred site 64 is found by first identifying the tibialtuberosity 62 on the anterior surface of the proximal tibia. Animaginery line is drawn from the tibial tuberosity to the median edge ofthe tibia 61. This line is equally divided 63 and the site of insertion64 is perpendicular and distal to 63. The preferred site 64 increases indistance from 63 with increasing age. In the newborn or infant thisdistance may be as short as 0.3-0.5 cm and increases to approximately2.5 cm by 6 years of age. Insertion at the level of the tibialtuberosity or distally, avoids insertion of the needle into the growthplate of the tibia. The distal medial tibia is also an excellent site.

With handle 50 firmly in the palm of the operator's hand, the needle isselectively directed toward the desired access site 63 and contact withthe bone is made. A back and forth twisting motion with slight pressurecauses the four cutting edges 44-47, or the three cutting edges 77-79,to cut into the bone. In other words, cutting edges 45 and 46 engage andcut into the bone when the needle is rotated clockwise, and cuttingedges 44 and 47 engage and cut into the bone when the needle is rotatedcounterclockwise. This enables flutes 41 and 42, as well as cuttingedges 77-79, to penetrate to the threaded section of the needle. Duringthe twisting motion, flutes 41 and 42, as well as the pyramid surfacesin the preferred embodiment, carry bone fragments out of the hole. Oncethe lead thread 36 of needle 10 reaches the hole 60, no further pressureis required. In the case of needle 70, the back and forth twistingmotion is continued until point 83 engages the bone. In other words,cutting edges 77, 78 and 79 cut into the bone when the needle is twistedclockwise and counterclockwise until point 83 of helical ridgeline 82engages the bone. After engaging the threads, the operator simply screwsthe needle clockwise into the marrow to the desired depth. Obviously thesize of the patient will determine how far to screw the needle in. Asthe needle is rotatably advanced, the design of the threads directs themarrow out and away from the side ports. A fluid injected through needle10, or 70, may then exit through side ports 33 and 34, or 75 and 76,unobstructed by marrow or other tissue which otherwise clogsconventional intraosseous needles.

With needle 10 or 70 in the desired position, handle 50 may be detachedfrom the needle by slight, manually applied, tensile pressuretherebetween. The appropriate drug administering mechanism such as asyringe or I.V. tubing may then be secured via the Luer-type fitting.After the patient has stabilized, venous access may be achieved andneedle 10 or 70 may be removed by detaching the I.V. tubing or syringefrom the needle and by re-securing handle 50 thereto. The needle 10 or70 may then be backed out by turning the needle counterclockwise.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly the preferred embodiment has been shown and described and that allchanges and modifications that come within the spirit of the inventionare desired to be protected.

What is claimed is:
 1. An intraosseous needle comprising:a one-pieceshaft having a longitudinal axis, a threaded portion, a proximal end, adistal end and a passageway extending from said proximal end partiallytoward said distal end, said shaft being rigid relative to bone; saiddistal end being formed into a solid boring tip that includes at leastone cutting edge capable of boring into bone when the needle is twistedabout said longitudinal axis with said boring tip pressed against thebone; and said shaft including at least one side port in fluidcommunication with said passageway and located proximally of said boringtip, said at least one side port being located in a valley between twoadjacent threads of said threaded portion without significantlyinterrupting said helical ridgeline.
 2. The intraosseous needle of claim1 wherein said boring tip has a pointed end.
 3. The intraosseous needleof claim 2 wherein said boring tip includes at least one clockwisecutting edge and at least one counterclockwise cutting edge.
 4. Theintraosseous needle of claim 3 wherein said at least one cutting edge isat least two cutting edges that terminate at said pointed end.
 5. Theintraosseous needle of claim 4 wherein said boring tip is formed in theshape of a three-sided pyramid having three cutting edges that intersectat said pointed end.
 6. The intraosseous needle of claim 5 wherein oneside port is axially aligned with one of said three cutting edges. 7.The intraosseous needle of claim 5 wherein said three-sided pyramidinterrupts at least one thread of said threaded portion; andsaid atleast one side port is located in a valley between two adjacent threadsuninterrupted by said three-sided pyramid.
 8. The intraosseous needle ofclaim 5 wherein said three-sided pyramid has a predetermined orientationabout said longitudinal axis with respect to said threaded portion. 9.The intraosseous needle of claim 8 wherein said at least one side portis no more than two side ports; andsaid two side ports are located about90 degrees apart about said longitudinal axis.
 10. The intraosseousneedle of claim 1 wherein each thread of said threaded portion includinga distal side facing said distal end, and a proximal side facing saidproximal end, and wherein the slope of each thread of said threads isshallower on said distal side than on said proximal side.
 11. Anintraosseous needle comprising:a one-piece shaft having an outersurface, a proximal end, a distal end and a passageway extending fromsaid proximal end toward said distal end; said outer surface of saidone-piece shaft being shaped to include a boring tip at said distal endthat is capable of boring into bone when said boring tip is pressedagainst the bone and said shaft is twisted; said outer surface of saidone-piece shaft also being shaped to include a threaded portion thatdefines a helical ridgeline which is interrupted by said boring tip; andat least one side port through said outer surface into fluidcommunication with said passageway, said at least one side port beinglocated in a valley between two adjacent threads of said threadedportion without significantly interrupting said helical ridgeline. 12.The intraosseous needle of claim 11 wherein said boring tip includescutting edges capable of boring into bone when said shaft is twistedboth clockwise and counterclockwise.
 13. The intraosseous needle ofclaim 12 wherein said boring tip has a pyramidal shape with a pointedend; andsaid pyramidal shape including a plurality of cutting edges thatintersect at said pointed end.
 14. The intraosseous needle of claim 13wherein said pyramidal shape is a three-sided pyramid.
 15. Theintraosseous needle of claim 13 wherein one side port is axially alignedwith one of said cutting edges.
 16. The intraosseous needle of claim 11wherein said boring tip includes a plurality of cutting edges;said shafthas a longitudinal axis; and said cutting edges, said helical ridgelineand said at least one side port have a predetermined angular orientationwith respect to each other about said longitudinal axis.
 17. Theintraosseous needle of claim 16 wherein said helical ridgeline coincidesat a point with one of said cutting edges; andone side port is axiallyaligned with one of said cutting edges.
 18. The intraosseous needle ofclaim 17 wherein said at least one side port is no more than two sideports; andsaid two side ports are located about 90 degrees apart aboutsaid longitudinal axis.
 19. An intraosseous needle comprising:aone-piece shaft having a longitudinal axis, a threaded portion, aproximal end, a distal end and a passageway extending from said proximalend partially toward said distal end, said shaft being rigid relative tobone, a thread of said threaded portion including a distal side facingsaid distal end and a proximal side facing said proximal end, the slopeof said thread being shallower on said distal side than on said proximalside; said distal end being formed into a solid boring tip that includesat least one cutting edge capable of boring into bone when the needle istwisted about said longitudinal axis with said boring tip pressedagainst the bone; and said shaft including at least one side port influid communication with said passageway and located proximally of saidboring tip.
 20. The intraosseous needle of claim 19 wherein said boringtip has a pointed end.
 21. The intraosseous needle of claim 20 whereinsaid boring tip includes at least one clockwise cutting edge and atleast one counterclockwise cutting edge.
 22. The intraosseous needle ofclaim 21 wherein said at least one cutting edge is at least two cuttingedges that terminate at said pointed end.
 23. The intraosseous needle ofclaim 22 wherein said boring tip is formed in the shape of a three-sidedpyramid having three cutting edges that intersect at said pointed end.24. The intraosseous needle of claim 23 wherein one side port is axiallyaligned with one of said three cutting edges.
 25. The intraosseousneedle of claim 23 wherein said three-sided pyramid interrupts at leastone thread of said threaded portion; andsaid at least one side port islocated in a valley between two adjacent threads uninterrupted by saidthree-sided pyramid.
 26. The intraosseous needle of claim 23 whereinsaid three-sided pyramid has a predetermined orientation about saidlongitudinal axis with respect to said threaded portion.
 27. Theintraosseous needle of claim 19 wherein said at least one side port islocated within said threaded portion.
 28. The intraosseous needle ofclaim 27 wherein said at least one side port is located in a valleybetween two adjacent threads of said threaded portion.
 29. Theintraosseous needle of claim 28 wherein said at least one side port isno more than two side ports; andsaid two side ports are located about 90degrees apart about said longitudinal axis.
 30. The intraosseous needleof claim 19 wherein the thread angle of said distal side of said threadis approximately 45°.
 31. An intraosseous needle comprising:a one-pieceshaft having a longitudinal axis, a threaded portion, a proximal end, adistal end and a passageway extending from said proximal end partiallytoward said distal end, said shaft being rigid relative to bone, eachthread of said threaded portion including a distal side facing saiddistal end and a proximal side facing said proximal end, the slope ofeach thread being shallower on said distal side than on said proximalside; said distal end being formed into a solid boring tip that includesat least one cutting edge capable of boring into bone when the needle istwisted about said longitudinal axis with said boring tip pressedagainst the bone; and said shaft including a plurality of side ports,said plurality of side porks in fluid communication with said passagewayand located proximally of said boring tip, and each of said plurality ofside ports being located substantially in a valley between two adjacentthreads of said threaded portion with no side port being locatedsubstantially outside of said valley.
 32. The intraosseous needle ofclaim 31 wherein said boring tip is formed in the shape of a three-sidedpyramid having three cutting edges that intersect at a point at saiddistal end.
 33. The intraosseous needle of claim 32 wherein one sideport is axially aligned with one of said three cutting edges.
 34. Theintraosseous needle of claim 32 wherein said three-sided pyramidinterrupts at least one thread of said threaded portion; andsaid atleast one side port is located in a valley between two adjacent threadsuninterrupted by said three-sided pyramid.
 35. The intraosseous needleof claim 32 wherein said three-sided pyramid has a predeterminedorientation about said longitudinal axis with respect to said threadedportion.